At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
As Clinical Site Management, we are the interface between Roche Diagnostics Study Teams and the external clinical study sites/Roche Customers performing the studies. Through a collaborative and strong study site relationship, we ensure study/site compliance with applicable regulations and guidelines; affirming the integrity of the generated data and preserving the safety of patients. It is with this expertise and mindset that Site Management facilitates successful clinical trials, which are essential to bringing Roche products to market. You will be responsible for site management activities for the assigned studies within the Infection & Immunity Sub-Chapter under the Study Delivery Diagnostic Solutions Chapter. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, and Sites.
You will adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness.
Deliver high quality and timely global study site management.
You will execute site management activities for sponsored studies for assigned area of focus for registrational purposes through all study phases.
You will work in local and global study teams, including virtual teams and exhibit diversity and cultural awareness.
Build and maintain strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders, in meeting business goals and ensuring operational excellence.
Good communication and interpersonal skills; Ability to successfully multi-task; Effective problem-solving skills; Strong ability to prioritize and aim for results.
Understanding of global regulatory, IRB and ethics committee submissions and support and/or coordinate submissions when needed; Knowledge and understanding of ICH/GCP and global regulatory guidelines/directives
Bachelor’s degree in chemistry, biology, other life sciences or a related field. Experience or background in IVD industry
3+ years of experience in clinical trials preferably in Infectious Diseases and experience in clinical trial preparation, execution and close out activities
Knowledge and understanding of ICH/GCP and global regulatory guidelines/directives/IVDR
Experience in using Sponsor and Site-related essential documents, including the use of CTMS for site creation & management, eTMF, etc
Familiarity in engaging with and coordinating third party service providers (CROs, Labs, etc.)
Strong analytical skills and attention to detail; handling ambiguity; in addition to great organization skills; Ability to participate and work effectively on multiple cross-functional teams.
Good communication and interpersonal skills; Ability to successfully multitask; Effective problem-solving skills; Strong ability to prioritize and aim for results
Are you are CRA (Clinical Research Associate) looking to make an impact in immunity and infectious diseases? We would love to hear from you.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
